Status:
WITHDRAWN
Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
Detailed Description
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
Eligibility Criteria
Inclusion
- Age 19 to 55 years
- BMI 18.5≥ and ≤27.0 kg/m²
- Female subjects must be menopause or surgically infertility.
- Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
- Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Exclusion
- History of hypersensitivity to investigational product
- Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
- The subject who is judged to be unsuitable as a test subject in a screening test.
- The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04393597
Start Date
May 28 2020
End Date
November 30 2020
Last Update
June 12 2020
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea